Device Classification Name |
airway, oropharyngeal, anesthesiology
|
510(k) Number |
K933760 |
Device Name |
STB GUEDEL AIRWAY |
Applicant |
SAVE-T-BREATH DISTRIBUTORS C.C. |
P.O.BOX 87523 |
HOUGHTON 2041 |
SOUTH AFRICA,
ZA
|
|
Applicant Contact |
C. NATES |
Correspondent |
SAVE-T-BREATH DISTRIBUTORS C.C. |
P.O.BOX 87523 |
HOUGHTON 2041 |
SOUTH AFRICA,
ZA
|
|
Correspondent Contact |
C. NATES |
Regulation Number | 868.5110
|
Classification Product Code |
|
Date Received | 08/03/1993 |
Decision Date | 03/23/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|